The U.S. Food and Drug Administration (FDA) is introducing a new web-based resource that describes some of the gene-drug interactions for which the agency believes there is sufficient scientific evidence to support the described associations between certain genetic variants, or genetic variant-inferred phenotypes, and altered drug metabolism, and in certain cases, differential therapeutic effects, including differences in risks of adverse events.
This resource represents a collaborative effort between the FDA’s Center for Devices and Radiological Health (CDRH) and Center for Drug Evaluation and Research (CDER) and is intended to provide the FDA’s current view of certain:
• Established gene-drug interactions that appear in FDA-approved drug labeling.
• Additional gene-drug interactions that are consistent with the current FDA labeling and are supported by sufficient scientific evidence based on published literature.
The FDA will continue to review the science and strength of the scientific evidence and update this resource periodically. The FDA has opened a docket FDA-2020-N-0839 for stakeholders to provide feedback.
